Systems of heart valve delivery

Abstract

A delivery system and method for delivering a prosthetic heart valve to the aortic valve. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

What is claimed is: 
     
         1 . A system for delivery of a prosthetic heart valve to a beating heart, comprising:
 a delivery catheter having a proximal control handle in which a proximal end of a balloon deflection tube is held and which extends distally therefrom, an expandable heart valve crimped on a distal balloon of the balloon deflection tube just distal to a deflectable portion of the balloon deflection tube, wherein the control handle further has an actuator on an exterior thereof for moving a tubular pusher body axially, the pusher body arranged to slide concentrically over the balloon deflection tube and having a proximal end terminating within the control handle, the pusher body extending distally from the control handle to a distal pusher sleeve which engages and is configured to push a proximal end of the balloon, wherein the actuator is affixed to and enables proximal retraction of the pusher body to disengage the pusher sleeve from the proximal end of the balloon, the control handle further enclosing a passive seal that moves with the pusher body and seals against blood leakage between the balloon deflection tube and the pusher body without preventing relative sliding movement therebetween.   
     
     
         2 . The system of  claim 1 , wherein the pusher sleeve is an outwardly flared distal end of the pusher body. 
     
     
         3 . The system of  claim 1 , wherein the proximal end of the pusher body affixes to a slider cap arranged to slide within a cavity in the control handle and which has an external ribbed slider forming the actuator. 
     
     
         4 . The system of  claim 3 , wherein the passive seal comprises at least one O-ring held within a bore of the slider cap. 
     
     
         5 . The system of  claim 1 , wherein the passive seal comprises a pair of adjacent O-rings. 
     
     
         6 . The system of  claim 5 , wherein the passive seal further comprises an annular polymer washer positioned between the pair of O-rings. 
     
     
         7 . The system of  claim 1 , wherein the control handle has mounted on an exterior thereof both the actuator and a deflection actuator for deflecting the deflectable portion of the balloon deflection tube via a deflection pull wire. 
     
     
         8 . The system of  claim 7 , wherein the deflection actuator and the actuator are located so as to enable one handed operation of both. 
     
     
         9 . The system of  claim 7 , wherein the deflection actuator is a trigger and the actuator is a slider. 
     
     
         10 . The system of  claim 7 , wherein the deflectable portion comprises a braided structure with a distal coil to which the deflection pull wire attaches. 
     
     
         11 . The system of  claim 1 , further including:
 an introducer that receives the delivery catheter therethrough and has an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around devices passed therethrough, the introducer having a length sufficient to extend from outside a patient through an intercostal incision and into the left ventricle of the patient, and   wherein the delivery catheter has a fluoroscopically-visible marker located proximal to the heart valve crimped on the balloon, and the introducer sheath has a fluoroscopically-visible marker on a distal tip thereof distinguishable from the marker of the delivery catheter.   
     
     
         12 . A system for delivery of a prosthetic heart valve to a beating heart, comprising:
 a delivery catheter having a proximal control handle in which a proximal end of a balloon tube is held and which extends distally therefrom, an expandable heart valve crimped on a distal balloon of the balloon tube, wherein the control handle further has an actuator on an exterior thereof for moving a tubular pusher body axially, the pusher body arranged to slide concentrically over the balloon tube and having a proximal end terminating within the control handle, the pusher body extending distally from the control handle to a distal pusher sleeve which engages and is configured to push a proximal end of the balloon, wherein the actuator is affixed to and enables proximal retraction of the pusher body to disengage the pusher sleeve from the proximal end of the balloon, the control handle further enclosing at least one O-ring that moves with the pusher body and seals around the balloon tube and prevents blood leakage between the balloon tube and the pusher body without preventing relative sliding movement therebetween.   
     
     
         13 . The system of  claim 12 , wherein the pusher sleeve is an outwardly flared distal end of the pusher body. 
     
     
         14 . The system of  claim 12 , wherein the proximal end of the pusher body affixes to a slider cap arranged to slide within a cavity in the control handle and which has an external ribbed slider forming the actuator. 
     
     
         15 . The system of  claim 14 , wherein the at least one O-ring is held within a bore of the slider cap. 
     
     
         16 . The system of  claim 12 , wherein the passive seal comprises a pair of adjacent O-rings. 
     
     
         17 . The system of  claim 16 , wherein the passive seal further comprises an annular polymer washer positioned between the pair of O-rings. 
     
     
         18 . The system of  claim 12 , wherein the control handle has mounted on an exterior thereof both the actuator and a deflection actuator for deflecting a deflectable portion of the balloon tube via a deflection pull wire, the deflectable portion being located just proximal to the balloon. 
     
     
         19 . The system of  claim 18 , wherein the deflection actuator and the actuator are located so as to enable one handed operation of both. 
     
     
         20 . The system of  claim 19 , wherein the deflection actuator is a trigger and the actuator is a slider.